PEW · Class II · 21 CFR 876.5530

FDA Product Code PEW: Implantable Transprostatic Tissue Retractor System

The Treatment Of Symptoms Due To Urinary Outflow Obstruction Secondary To Benign Prostatic Hyperplasia (bph) In Men Age 50 And Above.

Leading manufacturers include Neotract, Inc..

11
Total
10
Cleared
62d
Avg days
2013
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Implantable Transprostatic Tissue Retractor System Devices (Product Code PEW)

11 devices
1–11 of 11
Cleared Sep 22, 2023
UroLift 2 ATC Advanced Tissue Control System
K232558
Neotract, Inc.
Gastroenterology & Urology · 30d
Cleared Jul 31, 2020
UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2 Implant Cartridge
K201837
Neotract, Inc.
Gastroenterology & Urology · 29d
Cleared Jun 05, 2020
UroLift Advanced Tissue Control (ATC) System
K200441
Neotract, Inc.
Gastroenterology & Urology · 102d
Cleared Dec 20, 2019
UroLift System (UL400)
K193269
Neotract, Inc.
Gastroenterology & Urology · 24d
Cleared Mar 21, 2019
UroLift System UL400
K190377
Neotract, Inc.
Gastroenterology & Urology · 30d

About Product Code PEW - Regulatory Context

510(k) Submission Activity

11 total 510(k) submissions under product code PEW since 2013, with 10 receiving FDA clearance (average review time: 62 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.